FDA Cancels Emergency Use Authorization of Hydroxychloroquine for COVID-19

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On March 30, the U.S. Food and Drug Administration (FDA) granted the drugs hydroxychloroquine and chloroquine Emergency Use Authorization (EUA) for COVID-19. Today, the agency revoked the EUA.

The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.

The issue of whether either of the drugs, typically used to treat malaria, but also used to treat rheumatoid arthritis and lupus, were effective, has been controversial from the start. The attempt to use it initially was based on a study published in 2005 that found that chloroquine prevented the replication of the SARS-CoV-1 virus that caused SARS in laboratory studies.

In the midst of the China outbreak, production of the drug was ramped up for use in treatment. President Trump touted it as a “game-changer,” but drug and public health experts have been more conservative in their praise, saying that the drugs, chloroquine and hydroxychloroquine, have not been approved as treatments for COVID-19 and that for the most part, their effectiveness for treating COVID-19 are largely anecdotal. Trump later doubled down on the drug, claiming he was taking it prophylactically after potentially being exposed to two COVID-19-positive staffers.

Earlier this month, the medical journal The Lancet published a study suggesting that the drugs were ineffective. So did The New England Journal of Medicine. Then a few days later the authors withdrew the articles after discovering that the company providing the raw data, Surgisphere, refused to release its data, citing confidentiality concerns. Three of the authors of the study called for the retraction because they could “no longer vouch for the veracity of the primary data sources.”

Both The Lancet and The New England Journal of Medicine expressed concern over the data in Surgisphere’s QuartzClinical data analytic system. Reportedly, the system is capable of collecting huge amounts of data from more than 1,200 hospitals. However, both journals believe now that the database used inflated numbers that were significantly higher than official counts in those studies.

The EUA not only allowed physicians to use the drugs to treat COVID-19 but involved them being donated to the Strategic National Stockpile. Sandoz, a division of Novartis, donated 30 million doses of hydroxychloroquine and Bayer donated 1 million doses of chloroquine.

Under its review, the FDA revoked the authorization saying the drugs did not meet “the statutory criteria” for EUA because they weren’t likely to be effective based on the latest scientific data.

“FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” wrote FDA chief scientist Denise Hinton in a letter to Gary Disbrow of the Biomedical Advanced Research and Development Authority (BARDA).

The letter went on to say, “Accordingly, FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19. As of the date of this letter, the oral formulations of HCQ And CQ are no longer authorized by FDA to treat COVID-19.”

Last month, Stephen Hahn, commissioner of the FDA, published an open letter that seemed to defend the EUA, despite mounting evidence that did not support its effectiveness.

“This decision was based on evaluation of the EUA criteria and the scientific evidence available at that time,” Hahn wrote in that letter. “We continue to look at the data on hydroxychloroquine and chloroquine and we will make future determinations on these products based on available evidence including ongoing clinical studies.”

In addition to the apparent lack of efficacy in treating COVID-19, the drugs have potentially serious side effects.

The FDA, in its revocation, wrote, “Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use.”

Although The Lancet and NEJM articles have been retracted, numerous other studies have demonstrated no benefit with the two groups. For example, a study published in the Journal of Zhejiang University concluded the drugs were no better at treating COVID-19 than conventional care.

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